The European Parliament has sharpened its negotiating mandate for the regulation on cross-border health threats, which is currently in the trialogue.

At its meeting on 5 October, a large majority of MEPs concluded that the way the new EU Health Emergency preparedness and Response Authority (HERA) functions needed to be better aligned with European rules on cross-border health threats. This is not surprising, given that many MEPs are disappointed with the European Commission's proposal on HERA dated 14 September.

Others call the shots at HERA

The new mandate is a response to the European Commission's decision not to establish HERA as an independent crisis authority as announced, but to form only an administrative unit under the umbrella of the Directorate-General for Health (see also News September 2021). This decision came as a surprise to many. That too, on the legal basis of Article 122(1) Treaty on the Functioning of the European Union (TFEU), which gives the crucial decision-making power to the European Council. The European Parliament has no rights of co-determination - except indirectly in the release of funds from the relevant funding programmes.

Closing the democratic deficit

Quite a number of MEPs had raised concerns about the set-up and operation of HERA in recent weeks. Therefore, the ENVI Committee had updated its negotiating mandate on the "serious cross-border health threats" dossier by introducing additional targeted amendments. In the European parliamentary debate, Dr Peter Liese (EPP) explicitly emphasised that at least his group did not want to live permanently with the democratic deficit that had arisen with the present proposal. However, they are generally in favour of HERA. HERA was also needed to systematically promote cooperation between private companies and public institutions, in particular. The biotechnology company, Biontech from Mainz is a good example of this.

Disclosing contracts

Among other things, the European Parliament is now calling for transparency on all public investment in research, development, manufacture, production, procurement, stockpiling, supply and distribution of medical countermeasures. In the case of joint procurements, the European Commission must make the contracts and agreements publicly available in good time.

Involving the European Parliament

In addition, there will be close cooperation between the HERA Board, the Health Security Committee (HSC), the European Council's crisis mechanism and all relevant EU agencies and bodies. Duplication of work must be avoided and coherent decision-making at EU level must be ensured. A representative of the EP should also be seated at the table.

Developing the authority

HERA's work will be thoroughly reviewed by 2023; thereafter, every two years. The review should also be carried out with a view to upgrading HERA to an independent agency after all. A new legislative proposal could then be considered to take full account of the important role played by the European Parliament.

The amended text was adopted by 479 votes in favour, 71 against and 15 abstentions. Negotiations can now be resumed with the aim of reaching an early conclusion.